BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS CI522 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE

    MDR report key: 15189545 · Received August 9, 2022

    Report

    Report Number
    6000034-2022-02294
    Event Type
    Injury
    Date Received
    August 9, 2022
    Date of Event
    July 19, 2022
    Report Date
    July 19, 2022
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    UDI-DI
    09321502032599
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED ON AUGUST 09, 2022.

    Description of Event or Problem · 0

    PER THE CLINIC, THE PATIENT WAS PLACED UNDER SEDATION ON (B)(6), 2022 DURING THE INTEGRITY TEST PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253888 NUCLEUS CI522 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI522 NA 09321502032599

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Male Required Intervention